Healthy VolunteersPhase 1CBP276SADMADNCT07708831
Trial on Single/Multiple Ascending Doses for Safety, PK and PD for CBP-0276 in Healthy Subjects
A Phase 1 study testing CBP-0276 Acetate in people with Healthy Volunteers, run by Clarent Biopharma, Inc. at 2 sites in Mexico.
Trial summary
A double-blind, randomized, placebo-controlled, single and multiple ascending dose study with food effect to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CBP-0276. Incidence of potential related adverse events and laboratory abnormalities produced after investigational product vs. Read more about this study
- Who is it for?
- Ages 19 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CBP-0276 Acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesMexico
- Study dates
- 4 Sep 2025to 30 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 63 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinically healthy subject (male and female) aged ≥ 18 to ≤ 64 years. At least 50% of the population ≥ 45 years old.
- Be able and willing to read, understand, sign, and date the Informed Consent Form prior to entering the study.
- Be in good health at the discretion of the Principal Investigator, as determined by the results of a complete medical history by the physicians at the research site and laboratory tests performed by a certified Clinical Laboratory; Subjects with pre-existing medical conditions must be monitored and on stable doses of medication for a minimum period of 3 months at the screening visit.
- Woman of childbearing potential with negative serum pregnancy test at screening visit.
- Female with any of the following criteria:
- Postmenopausal, defined by cessation of menstruation for at least 12 consecutive months and confirmed by serum FSH levels > 40 mIU/mL and estradiol < 20 pg/mL at the screening visit or surgically sterile (with hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) and not undergoing in vitro fertilization or other fertility treatments.
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- Use 2 methods of contraception (one primary or highly effective and one secondary) within 90 days prior to the screening visit and up to at least 90 days after the end-of-study visit.
- Men must either agree to use contraception as described in the "Contraception and Pregnancy Testing" section, or remain abstinent (when it is the subject's usual and preferred lifestyle). They must also agree not to donate sperm for the duration of the study and until at least 90 days after the end-of-study visit.
- Body mass index from ≥ 18.5 to < 30.0 kg/m2 according to the Quetelet index at the screening visit.
- Non-smoker or former smoker, who has not used nicotine-containing products in any form, including nicotine patches or e-cigarettes, for 90 days prior to the Day 1 dose (first period, when applicable) and who has a negative urine cotinine test at the screening visit.
- Be willing to comply with all scheduled visits, treatment plan, lab tests, lifestyle considerations, restrictions, and other study procedures.
Who cannot join
- Medical history
- Pregnant or breastfeeding women.
- History of cardiac, endocrine, gastrointestinal, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, psychiatric or renal disease clinically significant or comorbidity of importance at the discretion of the Principal Investigator (or his/her delegate).
- History of allergic reactions, anaphylactic reactions, severe systemic hypersensitivity, or any allergic reaction that, in the opinion of the Principal Investigator or his/her delegate, is likely to be exacerbated by the investigational product.
- History of malignant or ongoing disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely removed and are considered cured at least 1 year before day 1 [first period, when applicable]).
- Systolic blood pressure in the supine position < 90 mmHg, >140 (18 to 59 years) or >160 (≥ 60 years); diastolic blood pressure > 90 or < 50 mmHg, heart rate >100 or < 40 beats per minute. Orthostatic decrease in systolic blood pressure >20 mmHg, orthostatic decrease in diastolic blood pressure >10 mmHg, or orthostatic increase in heart rate > 30 beats per minute. If any of the parameters are out of range, the measurements should be repeated two more times. Subjects will be excluded if the average of the 3 measurements is outside the corresponding reference range.
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- Clinically significant abnormalities (at the discretion of the Principal Investigator or his/her delegate) in the 12-lead electrocardiogram. QT interval corrected using Fridericia's correction method, QTcF > 450 ms for men and > 470 ms for women.
- Elective procedures or surgeries scheduled after signing the Informed Consent Form and until the end-of-study visit.
- History of gastric bypass/bariatric surgery or other gastrointestinal surgery that may affect gastric emptying or absorption of RAP-103 (excluding uncomplicated appendectomy and hernia repair performed at least 90 days prior to the screening visit).
- History of esophagitis and Barrett's esophagus.
- History of cholecystectomy.
- Use of pancreatic enzyme replacement within 30 days prior to the screening visit.
- Risk of infection
- History of human immunodeficiency virus or positive result in the HIV detection test (HIV 1-2 antibodies).
- History of hepatitis C infection or positive result in the detection test for antibodies against the hepatitis C virus (HCVAb).
- Current hepatitis B infection (defined as positive for HepBsAg and/or HepBcAb). Subjects with immunity to hepatitis B from prior natural infection (defined as HepBsAg negative, HepBcAb positive, and HepBsAb positive) or vaccination (defined as HepBsAg negative, HepBcAb negative, and HepBsAb positive) are eligible to participate in the study.
- Presence of chronic, recurrent, or severe infection (e.g., pneumonia, sepsis) at the discretion of the Principal Investigator, within 90 days prior to the screening visit and between the screening visit and day -1 (of the first period, when applicable).
- Presence of symptoms of bacterial, fungal or viral infection (including upper respiratory tract infection) within 14 days prior to the screening visit and between screening and day -1 (of the first period, when applicable). Subjects with local fungal infection (e.g., candidiasis, ringworm, tinea pedis) are eligible for reevaluation after successful treatment of the infection.
- Symptoms consistent with SARS-CoV-2 infection, at the discretion of the Principal Investigator or his/her delegate, within 14 days prior to day -1 (of the first period, when applicable), including, but not limited to: temperature >37.5 °C, sore throat, new and persistent cough, shortness of breath, diarrhea, muscle pain, or loss of taste or smell.
- Positive COVID-19 (SARS-CoV-2) test at the screening visit.
- Any immunization or vaccine administered within 30 days prior to day 1 (of the first period, when applicable).
- Lab Results
- 1. Abnormal and clinically significant results at the discretion of the Principal Investigator or his/her delegate and Sponsor, in the laboratory tests of the screening visit. Values out of range and determined to be not clinically significant at the discretion of the Principal Investigator or his/her delegate may be repeated on one occasion, the subject may be enrolled if the repeated value is within the normal range.
- Pre-medicated and concomitant medications
- Participation in any other investigational study with drugs, biologics, medical devices, or treatment with an investigational product or therapy approved for investigational use within the previous 3 months or 7 half-lives, whichever is greater, at day -1.
- Prior exposure to study treatment or prior participation in studies with CBP-0276
- Use of any prescription or over-the-counter medication (except acetaminophen ≤ 2 g daily, aspirin ≤ 325 mg daily, ibuprofen ≤ 600 mg, and hormonal contraceptives) within 14 days prior to day -1; and unwillingness or inability to refrain from use during study participation.
- Other
- History of alcohol or illegal drug abuse, positive urine drug test result at screening visit, positive urine drug test result, and/or positive breath alcohol test result on Day -1 (first period, when applicable), or use of illegal/recreational drugs during the development of the study.
- Habitual alcohol consumption > 14 drinks per week for men and > 7 drinks for women. One drink is equal to 12 ounces (360 mL) of beer, 1.5 ounces (45 mL) of hard liquor, or 5 ounces (150 mL) of wine.
- History or evidence of habitual use of tobacco or nicotine-containing products within 90 days prior to the Day 1 dose (first period, when applicable) and unwillingness to abstain from their use during study participation.
- Abnormal score on the C-SSRS and/or MMSE at the screening visit.
- Receipt of blood products within 2 months prior to the screening visit.
- Blood donation 3 months prior to the screening visit, plasma 2 weeks prior to the screening visit and platelets 6 weeks prior to the screening visit.
- Strenuous physical exercise (e.g., heavy lifting, weight training, calisthenics, and aerobic exercise) within 7 days prior to Day -1 (of the first period, when applicable). Walking at a normal pace is allowed.
- Unwillingness or inability to comply with the requirements of the protocol.
- Other unspecified reasons that, at the discretion of the Principal Investigator or the Sponsor, determine that the subject is not suitable for inclusion.
- Subjects who had been hospitalized in the 7 months prior to the screening visit.
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Centro de Investigación Clínica y Medicina Traslacional (CiMeT)
Guadalajara, Jalisco, 44340
Innovacion y Desarrollo en Ciencias de la Salud (IDeCSa)
Mexico City, 14090
About this study
Official title: Double Blind, Randomized, Placebo Controlled, Single and Multiple Ascending Doses and Food-effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CBP-0276 in Healthy Male and Female Subjects
A double-blind, randomized, placebo-controlled, single and multiple ascending dose study with food effect to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CBP-0276. Incidence of potential related adverse events and laboratory abnormalities produced after investigational product vs. placebo administration will be identified and analyzed. 64 subjects in total, 32 subjects in Part 1 (Single Dose Ascending:SAD) and 32 subjects in Part 2 (Multiple Dose Ascending:MAD). Healthy voluntieers (male and women), ≥ 18 to ≤ 64 years with at least least 50% of the population ≥ 45 years old will be included after sign of informed consent. Full sample in SAD and MAD will be divided in 4 subcohorts each. Subcohorts will receive 100mgQD of CBP-0276 or placebo (6:2), 200mgQD of CBP-0276 or placebo (6:2), 200mgBID of CBP-0276 or placebo (6:2) or 400mg QD of CBP-0276 or placebo (6:2). On MAD subjects will receive CBP-0276 during 14 days. The total duration of study participation for each subject (from the screening visit to the end-of-study visit) on SAD will be approximately 36 days for cohorts S1, S3, and S4 and approximately 43 days for cohort S2. The total duration of study participation for each subject (from the screening visit to the end-of-study visit) on MAD will be approximately 49 days for the M1, M2, M3, and M4 cohorts. After CBP-0276 administration plasma samples will be obtained to evaluate PK parameteres (AUC0-∞, AUC0-24, AUC0-tlast, AUC0-τ, %AUCextrap, Cmax, Ctrough, tlag, tmax.ss, t1/2, λz, MRT0-∞, CL/F, Vz/F, %Fluctuation, ARABC and ARCmax in plasma).
Read the detailed description
Phase I, double-blind, randomized, placebo-controlled clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of CBP-0276 in healthy male and female subjects. The study is divided into two parts: Part 1, a Single Ascending Dose (SAD) study, and Part 2, a Multiple Ascending Dose (MAD) study.
The trial intends to evaluate the safety and tolerability of single and multiple doses of CBP-0276, with primary outcomes including the incidence and severity of adverse events, as well as alterations in lab results, vital signs, and ECG readings. The secondary objectives are to evaluate the pharmacokinetics of CLT-0276, its linearity, and the effect of food on the drug's pharmacokinetics. Exploratory objectives include assessing scores from some neurological tests and different clinical biomarkers.
64 healthy subjects (32 in Part 1 and 32 in Part 2), aged 18 to 64 years, with at least 50% being 45 years or older will be included. Key inclusion criteria include being clinically healthy with a BMI between 18.5 and 30.0 kg/m2. Exclusion criteria are strict and include a history of significant diseases, clinically abnormal lab or ECG results, recent use of medications or illegal drugs, and a history of substance abuse.
The study will take place in two research centers in Mexico. The investigational product, CBP-0276, will be administered orally in capsule form. Doses will range from 100 mg to 400 mg, single dose. Part 1 includes four cohorts (S1-S4) where subjects will receive either a single dose of CBP-0276 or a placebo, with one cohort (S2) dedicated to assessing the food effect. Part 2 consists of four cohorts (M1-M4) with multiple doses to evaluate steady-state pharmacokinetics.
Informed Consent will be obtained prior to any study procedures, and information will be kept confidential. Adverse events will be monitored, classified by severity (mild, moderate, or severe), and assessed for causality. Any protocol deviations must be documented and reported to the Sponsor and the Institutional Ethics Committee (IEC). The protocol also specifies procedures for handling pregnancies, with the Principal Investigator required to report any occurrences to the Sponsor and the appropriate regulatory bodies.
Safety Monitoring Committee (SMC), an independent, multidisciplinary group, will oversee the safety of the subjects and advise on whether the study should continue, be modified, or be terminated.
For the safety objective, the incidences of adverse events, alterations in laboratory tests, and alterations in the subjects' 12-lead ECG will be estimated by treatment cohort and total. Adverse events, laboratory abnormalities, and 12-lead ECG abnormalities will be defined according to MedDRA and summarized through frequency tables for each treatment cohort and total by system and preferred system term. The frequency tables will be presented in full and by level of severity. Tolerability will be measured through two times before the occurrence of the first adverse event, laboratory abnormality, or 12-lead ECG abnormality and Event duration time and analyzed through survival analyses; and will be compared between the cohorts through the Kaplan Meier model.
- Conditions
- Healthy Volunteers
- Being tested
- CBP-0276 Acetate, Placebo for CBP-0276 Acetate
- Keywords
- Single Ascendent Dose, Multiple Ascendent Dose, RCT Phase 1, CBP-0276
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBP-0276 AcetateDrug
Also called Active
CBP-0276 Acetate
Placebo for CBP-0276 AcetateDrug
Also called Control
Placebo for CBP-0276 Acetate: 100 mg of microcrystalline cellulose microcrystals (MCC)
| Study group | Role | What they receive |
|---|---|---|
| SAD 1 | Experimental | SAD 1 (6 on active 100mg CBP-0276 single dose and 2 on placebo) Receives: Drug: CBP-0276 Acetate; Drug: Placebo for CBP-0276 Acetate |
| SAD 2 | Experimental | SAD 2 (6 on active 200mg CBP-0276 single dose and 2 on placebo) Receives: Drug: CBP-0276 Acetate; Drug: Placebo for CBP-0276 Acetate |
| SAD 3 | Experimental | SAD 3 (6 on active 200mg CBP-0276 BID and 2 on placebo) Receives: Drug: CBP-0276 Acetate; Drug: Placebo for CBP-0276 Acetate |
| SAD 4 | Experimental | SAD 4 (6 on active 400mg CBP-0276 single dose and 2 on placebo) Receives: Drug: CBP-0276 Acetate; Drug: Placebo for CBP-0276 Acetate |
| MAD 1 | Experimental | MAD 1 (6 on active 100mg CBP-0276 one dose a day for 14 days and 2 on placebo) Receives: Drug: CBP-0276 Acetate; Drug: Placebo for CBP-0276 Acetate |
| MAD 2 | Experimental | MAD 2 (6 on active 200mg CBP-0276 one dose a day for 14 days and 2 on placebo) Receives: Drug: CBP-0276 Acetate; Drug: Placebo for CBP-0276 Acetate |
| MAD 3 | Experimental | MAD 3 (6 on active 200mg CBP-0276 BID for 14 days and 2 on placebo) Receives: Drug: CBP-0276 Acetate; Drug: Placebo for CBP-0276 Acetate |
| MAD 4 | Experimental | MAD 4 (6 on active 400mg CBP-0276 one dose a day for 14 days and 2 on placebo) Receives: Drug: CBP-0276 Acetate; Drug: Placebo for CBP-0276 Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Incidence of adverse events
Measured: 36 hours after randomization for SAD and 15 days after randomization for for MAD
Severity of adverse events
Severity of adverse events evaluated according MEDRA
Measured: 36 hours after randomization for SAD and 15 days after randomization for for MAD
Alterations systolic blood pressure
Evaluation of systolic blood presure. Minimal valure must be 100 mm Hg and maximum 140mm HG
Measured: 36 hours after randomization for SAD and 15 days after randomization for for MAD
Time until first adverse event
The length of time until the first adverse event
Measured: 36 hours after randomization for SAD and 15 days after randomization for for MAD
Duration of adverse events.
The length of time for Duration of adverse events.
Measured: 36 hours after randomization for SAD and 15 days after randomization for for MAD
Duration of the QRT interval in electrocardiogram
Incidence of alterations in the 12-lead electrocardiogram.
Measured: evalution o QRT by electro36 hours after randomization for SAD and 15 days after randomization for for MAD
Secondary outcomes (7)
Area under the curve 0 to infinity
Area under the concentration curve in time from moment 0 to infinity
Measured: evaaluation o QRT intervlo by electrocardiogram24h and at day 7 post randomization for SAD and during 15 days for MAD
Area under the curve 0-24H (AUc)
Area under the concentration curve in time from time 0 to 24 hours
Measured: Auc analyzed by plasma lvel at24 days and day 7 after randomization for SAD and 15 days for MAD
Area under curve 0 to last quantifiable concentration (AUc o-LQC)
Area under the concentration curve in time from time 0 to the last quantifiable concentration
Measured: Auc0-lqc analyzed by plasma lvel at24h and day 7 after randomization for SAD and 15 days for MAD
Area under curve over time during administration interval(A°UC 0-dai)|
Area under the concentration curve over time during an administration interval
Measured: Aucd0-sDAI analyzed by plasma lvel at24h and day 7 after randomization for SAD and 15 days for MAD
Area under curve extrapolated(AUCext
Area under curve extrapolated
Measured: Aucext analyzed by plasma lvel at24h and day 7 after randomization for SAD and 15 days for MAD
Peak plasma concentration (ppc)
Peak plasma concentration after CBP-0276 Adimistration
Measured: ppc tsken by plasma levels o RAP103 at24h and day 7 after randomization for SAD and 15 days for MAD
Concentration at end of dosing range<<(cEDR9
Concentration measured at the end of the dosing range
Measured: cedr taken by plasma levels o RAP103 at24h and day 7 after randomization for SAD and 15 days for MAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start4 Sep 2025
- Primary completion16 Feb 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase I, double-blind, randomized, placebo-controlled clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of CBP-0276 in healthy male and female subjects. The study is divided into two parts: Part 1, a Single Ascending Dose (SAD) study, and Part 2, a Multiple Ascending Dose (MAD) study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarent Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan MA Garcia Lara, MD, MSc, Principal investigator, Innovación y Desarrollo en Ciencias de la Salud SRL de CVOmar Cárdenas Sáenz, MD, MSc, Principal investigator, Centro de Investigación Clínica y Medicina Translacional (CIMeT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708831
- Sponsor's protocol ID
- CBP276SADMAD
- Acronym
- CBP276SADMAD
- Status last verified
- Jul 2026
- First submitted
- 8 Sep 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non sensitive clinical, biomarkers and some PK parameters will be allocated on a public data base repository. Any atempt to evaluate the DB must be advise to responsible
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized, Placebo Controlled, Single and Multiple Ascending Doses and Food-effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CBP-0276 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT07708831
- Acronym / sponsor ID
- CBP276SADMAD / CBP276SADMAD
- Conditions
- Healthy Volunteers
- Keywords
- Single Ascendent Dose, Multiple Ascendent Dose, RCT Phase 1, CBP-0276
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Clarent Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double-blind, randomized, placebo-controlled, single and multiple ascending dose study with food effect to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CBP-0276. Incidence of potential related adverse events and laboratory abnormalities produced after investigational product vs. placebo administration will be identified and analyzed. 64 subjects in total, 32 subjects in Part 1 (Single Dose Ascending:SAD) and 32 subjects in Part 2 (Multiple Dose Ascending:MAD). Healthy voluntieers (male and women), ≥ 18 to ≤ 64 years with at least least 50% of the population ≥ 45 years old will be included after sign of informed consent. Full sample in SAD and MAD will be divided in 4 subcohorts each. Subcohorts will receive 100mgQD of CBP-0276 or placebo (6:2), 200mgQD of CBP-0276 or placebo (6:2), 200mgBID of CBP-0276 or placebo (6:2) or 400mg QD of CBP-0276 or placebo (6:2). On MAD subjects will receive CBP-0276 during 14 days. The total duration of study participation for each subject (from the screening visit to the end-of-study visit) on SAD will be approximately 36 days for cohorts S1, S3, and S4 and approximately 43 days for cohort S2. The total duration of study participation for each subject (from the screening visit to the end-of-study visit) on MAD will be approximately 49 days for the M1, M2, M3, and M4 cohorts. After CBP-0276 administration plasma samples will be obtained to evaluate PK parameteres (AUC0-∞, AUC0-24, AUC0-tlast, AUC0-τ, %AUCextrap, Cmax, Ctrough, tlag, tmax.ss, t1/2, λz, MRT0-∞, CL/F, Vz/F, %Fluctuation, ARABC and ARCmax in plasma).
Detailed description
Phase I, double-blind, randomized, placebo-controlled clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of CBP-0276 in healthy male and female subjects. The study is divided into two parts: Part 1, a Single Ascending Dose (SAD) study, and Part 2, a Multiple Ascending Dose (MAD) study.
The trial intends to evaluate the safety and tolerability of single and multiple doses of CBP-0276, with primary outcomes including the incidence and severity of adverse events, as well as alterations in lab results, vital signs, and ECG readings. The secondary objectives are to evaluate the pharmacokinetics of CLT-0276, its linearity, and the effect of food on the drug's pharmacokinetics. Exploratory objectives include assessing scores from some neurological tests and different clinical biomarkers.
64 healthy subjects (32 in Part 1 and 32 in Part 2), aged 18 to 64 years, with at least 50% being 45 years or older will be included. Key inclusion criteria include being clinically healthy with a BMI between 18.5 and 30.0 kg/m2. Exclusion criteria are strict and include a history of significant diseases, clinically abnormal lab or ECG results, recent use of medications or illegal drugs, and a history of substance abuse.
The study will take place in two research centers in Mexico. The investigational product, CBP-0276, will be administered orally in capsule form. Doses will range from 100 mg to 400 mg, single dose. Part 1 includes four cohorts (S1-S4) where subjects will receive either a single dose of CBP-0276 or a placebo, with one cohort (S2) dedicated to assessing the food effect. Part 2 consists of four cohorts (M1-M4) with multiple doses to evaluate steady-state pharmacokinetics.
Informed Consent will be obtained prior to any study procedures, and information will be kept confidential. Adverse events will be monitored, classified by severity (mild, moderate, or severe), and assessed for causality. Any protocol deviations must be documented and reported to the Sponsor and the Institutional Ethics Committee (IEC). The protocol also specifies procedures for handling pregnancies, with the Principal Investigator required to report any occurrences to the Sponsor and the appropriate regulatory bodies.
Safety Monitoring Committee (SMC), an independent, multidisciplinary group, will oversee the safety of the subjects and advise on whether the study should continue, be modified, or be terminated.
For the safety objective, the incidences of adverse events, alterations in laboratory tests, and alterations in the subjects' 12-lead ECG will be estimated by treatment cohort and total. Adverse events, laboratory abnormalities, and 12-lead ECG abnormalities will be defined according to MedDRA and summarized through frequency tables for each treatment cohort and total by system and preferred system term. The frequency tables will be presented in full and by level of severity. Tolerability will be measured through two times before the occurrence of the first adverse event, laboratory abnormality, or 12-lead ECG abnormality and Event duration time and analyzed through survival analyses; and will be compared between the cohorts through the Kaplan Meier model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- Phase I, double-blind, randomized, placebo-controlled clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of CBP-0276 in healthy male and female subjects. The study is divided into two parts: Part 1, a Single Ascending Dose (SAD) study, and Part 2, a Multiple Ascending Dose (MAD) study.
| Arm | Type | Receives |
|---|---|---|
| SAD 1 | Experimental | Drug: CBP-0276 Acetate, Drug: Placebo for CBP-0276 AcetateSAD 1 (6 on active 100mg CBP-0276 single dose and 2 on placebo) |
| SAD 2 | Experimental | Drug: CBP-0276 Acetate, Drug: Placebo for CBP-0276 AcetateSAD 2 (6 on active 200mg CBP-0276 single dose and 2 on placebo) |
| SAD 3 | Experimental | Drug: CBP-0276 Acetate, Drug: Placebo for CBP-0276 AcetateSAD 3 (6 on active 200mg CBP-0276 BID and 2 on placebo) |
| SAD 4 | Experimental | Drug: CBP-0276 Acetate, Drug: Placebo for CBP-0276 AcetateSAD 4 (6 on active 400mg CBP-0276 single dose and 2 on placebo) |
| MAD 1 | Experimental | Drug: CBP-0276 Acetate, Drug: Placebo for CBP-0276 AcetateMAD 1 (6 on active 100mg CBP-0276 one dose a day for 14 days and 2 on placebo) |
| MAD 2 | Experimental | Drug: CBP-0276 Acetate, Drug: Placebo for CBP-0276 AcetateMAD 2 (6 on active 200mg CBP-0276 one dose a day for 14 days and 2 on placebo) |
| MAD 3 | Experimental | Drug: CBP-0276 Acetate, Drug: Placebo for CBP-0276 AcetateMAD 3 (6 on active 200mg CBP-0276 BID for 14 days and 2 on placebo) |
| MAD 4 | Experimental | Drug: CBP-0276 Acetate, Drug: Placebo for CBP-0276 AcetateMAD 4 (6 on active 400mg CBP-0276 one dose a day for 14 days and 2 on placebo) |
Who may qualify
- Ages
- 19 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Clinically healthy subject (male and female) aged ≥ 18 to ≤ 64 years. At least 50% of the population ≥ 45 years old.
- Be able and willing to read, understand, sign, and date the Informed Consent Form prior to entering the study.
- Be in good health at the discretion of the Principal Investigator, as determined by the results of a complete medical history by the physicians at the research site and laboratory tests performed by a certified Clinical Laboratory; Subjects with pre-existing medical conditions must be monitored and on stable doses of medication for a minimum period of 3 months at the screening visit.
- Woman of childbearing potential with negative serum pregnancy test at screening visit.
- Female with any of the following criteria:
Key exclusion criteria (38 listed)
- Medical history
- Pregnant or breastfeeding women.
- History of cardiac, endocrine, gastrointestinal, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, psychiatric or renal disease clinically significant or comorbidity of importance at the discretion of the Principal Investigator (or his/her delegate).
- History of allergic reactions, anaphylactic reactions, severe systemic hypersensitivity, or any allergic reaction that, in the opinion of the Principal Investigator or his/her delegate, is likely to be exacerbated by the investigational product.
- History of malignant or ongoing disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely removed and are considered cured at least 1 year before day 1 [first period, when applicable]).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBP-0276 AcetateAlso: ActiveCBP-0276 Acetate | Drug | MAD 1, MAD 2, MAD 3, MAD 4, SAD 1, SAD 2, SAD 3, SAD 4 |
| Placebo for CBP-0276 AcetateAlso: ControlPlacebo for CBP-0276 Acetate: 100 mg of microcrystalline cellulose microcrystals (MCC) | Drug | MAD 1, MAD 2, MAD 3, MAD 4, SAD 1, SAD 2, SAD 3, SAD 4 |
Primary outcome
Incidence of adverse events
Time frame: 36 hours after randomization for SAD and 15 days after randomization for for MAD
Incidence of adverse events
Severity of adverse events
Time frame: 36 hours after randomization for SAD and 15 days after randomization for for MAD
Severity of adverse events evaluated according MEDRA
Alterations systolic blood pressure
Time frame: 36 hours after randomization for SAD and 15 days after randomization for for MAD
Evaluation of systolic blood presure. Minimal valure must be 100 mm Hg and maximum 140mm HG
Time until first adverse event
Time frame: 36 hours after randomization for SAD and 15 days after randomization for for MAD
The length of time until the first adverse event
Duration of adverse events.
Time frame: 36 hours after randomization for SAD and 15 days after randomization for for MAD
The length of time for Duration of adverse events.
Duration of the QRT interval in electrocardiogram
Time frame: evalution o QRT by electro36 hours after randomization for SAD and 15 days after randomization for for MAD
Incidence of alterations in the 12-lead electrocardiogram.
7 secondary outcomes
Area under the curve 0 to infinity
Time frame: evaaluation o QRT intervlo by electrocardiogram24h and at day 7 post randomization for SAD and during 15 days for MAD
Area under the curve 0-24H (AUc)
Time frame: Auc analyzed by plasma lvel at24 days and day 7 after randomization for SAD and 15 days for MAD
Area under curve 0 to last quantifiable concentration (AUc o-LQC)
Time frame: Auc0-lqc analyzed by plasma lvel at24h and day 7 after randomization for SAD and 15 days for MAD
Area under curve over time during administration interval(A°UC 0-dai)|
Time frame: Aucd0-sDAI analyzed by plasma lvel at24h and day 7 after randomization for SAD and 15 days for MAD
Area under curve extrapolated(AUCext
Time frame: Aucext analyzed by plasma lvel at24h and day 7 after randomization for SAD and 15 days for MAD
Peak plasma concentration (ppc)
Time frame: ppc tsken by plasma levels o RAP103 at24h and day 7 after randomization for SAD and 15 days for MAD
Concentration at end of dosing range<<(cEDR9
Time frame: cedr taken by plasma levels o RAP103 at24h and day 7 after randomization for SAD and 15 days for MAD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. Non sensitive clinical, biomarkers and some PK parameters will be allocated on a public data base repository. Any atempt to evaluate the DB must be advise to responsible
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan MA Garcia Lara, MD, MSc principal investigator
Innovación y Desarrollo en Ciencias de la Salud SRL de CV
Omar Cárdenas Sáenz, MD, MSc principal investigator
Centro de Investigación Clínica y Medicina Translacional (CIMeT)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBP-0276 Acetate in people with Healthy Volunteers, run by Clarent Biopharma, Inc. at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: 36 hours after randomization for SAD and 15 days after randomization for for MAD). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.