AsthmaPhase 1NCT03567694
Single and Multiple Doses of HA115 and Food Effect in Healthy Adult Volunteers
A Phase 1 study testing HA115 in people with Asthma, run by Conjupro Biotherapeutics, Inc. at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled Phase 1 study of HA115 capsules administered orally to healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- HA115
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 12 Oct 2022
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females, 18-55 year old, inclusive, with body mass index (BMI) between 18 and 30 kg/m2, inclusive, and body weight not less than 50 kg.
- In good general health, free from clinically significant medical or psychiatric illness or disease (as determined by medical/surgical history, physical examination, weight, 12-lead ECG, and clinical laboratory tests).
- with normal cardiac conduction and function at screening
- Nonsmoker within the previous 6 months (before screening), and does not use tobacco containing, or nicotine-containing products
- Has normal clinical chemistry, hematology, coagulation, and complete urinalysis (fasted for at least 8 hours) results at screening and Day -1
- Has a negative urine drug screen result at screening and on Day -1.
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- For all female participants, have a negative urine pregnancy test at screening and on Day -1, and must not be breastfeeding. Female participants of childbearing potential must agree to use a protocol-approved method of non-hormonal contraception as detailed in Appendix 4 from signing of the informed consent, throughout the duration of the study and for 30 days after the last dose of study drug.
- Male participants who are nonsterilized and sexually active with a female partner of childbearing potential must agree to use a protocol-approved method of non-hormonal contraception as detailed in Appendix 4 from signing of the informed consent, throughout the duration of the study and for 30 days after the last dose of study drug.
- Male participants must agree to not donate sperm during the study and for 3 months (90 days) after receiving the last dose of study drug.
Who cannot join
- Has a history of or current clinically significant medical illness including (but not limited to) pulmonary, cardiovascular, coagulation disorders, lipid abnormalities, gastrointestinal, immunologic, endocrine, neurologic, psychiatric, or thromboembolic disease, metabolic disturbances, or any other current physical condition that the investigator considers should exclude the participant, or that could interfere with the interpretation of the study results.
- Has current or recent (within 6 months) history of gastrointestinal disease (except for appendectomy, inguinal/umbilical hernia), or any surgical or medical condition such as Crohn's disease or liver disease, that could potentially alter the absorption, metabolism, or excretion of the study drugs.
- Has any clinically significant medical condition, physical examination finding, ECG abnormality, or clinically significant abnormal value for clinical chemistry, hematology, coagulation, or urinalysis at Screening or at admission to the study center, as deemed appropriate by the investigator.
- Has any of the following (participant may rescreen once for failure to meet criteria at Screening):
- SBP >150 mmHg at Screening stable (measured in supine position)
- DBP of >95 mmHg at Screening stable (measured in supine position).
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- History or presence of malignancy within the past 5 years, except for adequately treated localized skin cancer (basal cell or squamous cell carcinoma), which is allowed.
- Currently suffers from clinically significant systemic allergic disease, or has a history of significant drug allergies, including but not limited to:
- A history of anaphylactic reaction
- Allergic reaction due to any drug that led to significant morbidity
- Known hypersensitivity to any component of the formulation of HA115.
- Has donated blood or had an acute loss of blood (>500 mL) during the 3 months before study drug administration or intends to donate blood or blood products within 3 months after the completion of the study.
- Has had an acute, clinically significant illness within 30 days prior to Day 1, or has had a recent febrile illness with an abnormal body temperature for at least 72 hours before dosing on Day 1.
- Has a history (within the past 12 months before Screening) of drug abuse (defined as any illicit drug use), or a history of alcohol abuse (defined as alcohol consumption exceeding 14 units per week), or a positive test for drugs of abuse at Screening or upon admittance to the testing facility (Day -1) or is unwilling to abstain from alcohol and drugs of abuse throughout the study.
- Has a smoking history during the past 6 months before Screening. This includes the use of any nicotine containing substances (e.g., nicotine patch or gum, chewing tobacco, e cigarettes), or has a positive cotinine test at Screening or Day -1, or is unwilling to abstain from these products for the duration of the study.
- Has ever received HA115 in a previous clinical study or has used any investigational compound and/or an experimental medical device within 3 months before study drug administration.
- If male, the participant intends to impregnate others, or donate sperm during this study or for 3 months after receiving the last dose of study drug.
- Has inadequate venous access for the required blood draws for the study.
- Is unable to meet or perform study requirements or has a known or suspected inability to comply with the study protocol.
- Is unable or unwilling to eat provided food (e.g., vegetarian, kosher, lactose intolerant dietary requirements).
- Is an immediate family member of the investigator, or an employee of the study center with direct involvement in the proposed study or other studies under the direction of the investigator or study center or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling), or may consent under duress.
- Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
- Has participated in another clinical trial within 60 days prior to the first dose of study medication.
- Use of any over-the-counter (OTC) medication (including nutritional or dietary supplements, herbal preparations, or vitamins) within 7 days prior to the first dose of study medication until the end of study visit without evaluation and approval by the investigator.
- Use of any prescription medication from 14 days prior to the first dose of study medication until the end-of-study visit.
- Has been treated with any known drugs that are moderate or strong inhibitors/inducers of cytochrome P450 (CYP) enzymes (e.g., barbiturates, phenothiazines, cimetidine, carbamazepine) within 30 days prior to the first dose of study medication, and that, in the investigator's judgment, may impact participant safety or the validity of the study results.
- Engagement in strenuous exercise from 48 hours prior to the first dose of study medication until the end-of-study visit.
- Consumption of beverages or foods that contain alcohol, grapefruit, poppy seeds, broccoli, Brussel sprouts, pomegranate, star fruit, char-grilled meat, or caffeine/xanthine from 48 hours prior to the first dose of study medication until the end of study visit. P25. Is a female participant with a positive pregnancy test result.
- Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double-Blind Placebo-controlled Ascending Dose FIH Study to Evaluate Single and Multiple Doses of HA115 in Healthy Volunteers and to Investigate Food Effect on Pharmacokinetics After Single Oral Doses of HA115
This is a randomized, double-blind, placebo-controlled Phase 1 study of HA115 capsules administered orally to healthy adult volunteers.
Read the detailed description
The study consists of 2 parts, Part A (SAD, including fed/fasted comparison) and Part B (MAD). Part A will be a randomized, double blind, placebo controlled, dose-escalating titration of up to 8 single dose levels of HA115. In each cohort, 8 participants will receive active compound and 2 will receive placebo in a randomized manner. Part A will include an assessment of the effect of a high-fat breakfast on the absorption and PK profile of HA115, performed in 10 participants at a single dose to be selected based on SAD results and predicted to be associated with therapeutic plasma concentrations.
Part B will be a randomized, double-blind, placebo controlled parallel group study of up to 3 dose levels of HA115 given once daily. The number of days of dosing will be based on the results of the PK analysis from Part A. In each cohort, 8 participants will receive active compound fasted and 2 will receive placebo in a randomized, double blind fashion. Safety observations and PK evaluations will be made. Safety data will be reviewed with the SRC prior to each dose escalation.
- Conditions
- Asthma
- Being tested
- HA115, Placebo
- Keywords
- asthma, allergic rhinitis, HA115, CRTH2 antagonists, CT133
- Medical subject headings
- Asthma, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA115Drug
Test Drug
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose and Food effect | Experimental | This is the SAD / Food effect arm. For SAD, a total of 80 subjects will be enrolled into 8 groups of 10 subjects each; within each group, 8 will receive HA115 at a single ascending dose 10, 25, 50, 100, 200, 400, 800, 1200 mg, and 2 subjects will be placebo control. For food effect study,10 participants will be administered HA115 at a single dose to be selected based on SAD results. Receives: Drug: HA115; Drug: Placebo |
| Multiple Ascending Dose | Experimental | For the MAD portion, 3 dose levels will be selected based on SAD results. Receives: Drug: HA115; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event (AE)
Percentage of subjects experiencing adverse event (AE).
Measured: 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Oct 2021 (estimated)
- Primary completion10 Oct 2022 (estimated)
- Study completion12 Oct 2022 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Sequential
- Model description
- The study consists of 2 parts, Part A (SAD, including fed/fasted comparison) and Part B (MAD). Part A will include an assessment of the effect of a high-fat breakfast on the absorption and PK profile of HA115, performed in 10 participants at a single dose to be selected based on SAD results and predicted to be associated with therapeutic plasma concentrations. Part B will be a randomized, double-blind, placebo controlled parallel group study of up to 3 dose levels of HA115 given once daily. The number of days of dosing will be based on the results of the PK analysis from Part A. In each cohort, 8 participants will receive active compound fasted and 2 will receive placebo in a randomized, double blind fashion. Safety observations and PK evaluations will be made. Safety data will be reviewed with the SRC prior to each dose escalation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conjupro Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Officials, Study director, Conjupro Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567694
- Sponsor's protocol ID
- CSPC-HA115-US-101
- Status last verified
- Aug 2021
- First submitted
- 7 Jun 2018
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Placebo-controlled Ascending Dose FIH Study to Evaluate Single and Multiple Doses of HA115 in Healthy Volunteers and to Investigate Food Effect on Pharmacokinetics After Single Oral Doses of HA115
- ClinicalTrials.gov ID
- NCT03567694
- Acronym / sponsor ID
- CSPC-HA115-US-101
- Conditions
- Asthma
- Keywords
- asthma, allergic rhinitis, HA115, CRTH2 antagonists, CT133
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Conjupro Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 10 Oct 2022 (estimated)
- Study completion
- 12 Oct 2022 (estimated)
- First posted
- 26 Jun 2018 (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.
This is a randomized, double-blind, placebo-controlled Phase 1 study of HA115 capsules administered orally to healthy adult volunteers.
Detailed description
The study consists of 2 parts, Part A (SAD, including fed/fasted comparison) and Part B (MAD). Part A will be a randomized, double blind, placebo controlled, dose-escalating titration of up to 8 single dose levels of HA115. In each cohort, 8 participants will receive active compound and 2 will receive placebo in a randomized manner. Part A will include an assessment of the effect of a high-fat breakfast on the absorption and PK profile of HA115, performed in 10 participants at a single dose to be selected based on SAD results and predicted to be associated with therapeutic plasma concentrations.
Part B will be a randomized, double-blind, placebo controlled parallel group study of up to 3 dose levels of HA115 given once daily. The number of days of dosing will be based on the results of the PK analysis from Part A. In each cohort, 8 participants will receive active compound fasted and 2 will receive placebo in a randomized, double blind fashion. Safety observations and PK evaluations will be made. Safety data will be reviewed with the SRC prior to each dose escalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study consists of 2 parts, Part A (SAD, including fed/fasted comparison) and Part B (MAD). Part A will include an assessment of the effect of a high-fat breakfast on the absorption and PK profile of HA115, performed in 10 participants at a single dose to be selected based on SAD results and predicted to be associated with therapeutic plasma concentrations. Part B will be a randomized, double-blind, placebo controlled parallel group study of up to 3 dose levels of HA115 given once daily. The number of days of dosing will be based on the results of the PK analysis from Part A. In each cohort, 8 participants will receive active compound fasted and 2 will receive placebo in a randomized, double blind fashion. Safety observations and PK evaluations will be made. Safety data will be reviewed with the SRC prior to each dose escalation.
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose and Food effect | Experimental | Drug: HA115, Drug: PlaceboThis is the SAD / Food effect arm. For SAD, a total of 80 subjects will be enrolled into 8 groups of 10 subjects each; within each group, 8 will receive HA115 at a single ascending dose 10, 25, 50, 100, 200, 400, 800, 1200 mg, and 2 subjects will be placebo control. For food effect study,10 participants will be administered HA115 at a single dose to be selected based on SAD results. |
| Multiple Ascending Dose | Experimental | Drug: HA115, Drug: PlaceboFor the MAD portion, 3 dose levels will be selected based on SAD results. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy males or females, 18-55 year old, inclusive, with body mass index (BMI) between 18 and 30 kg/m2, inclusive, and body weight not less than 50 kg.
- In good general health, free from clinically significant medical or psychiatric illness or disease (as determined by medical/surgical history, physical examination, weight, 12-lead ECG, and clinical laboratory tests).
- with normal cardiac conduction and function at screening
- Nonsmoker within the previous 6 months (before screening), and does not use tobacco containing, or nicotine-containing products
- Has normal clinical chemistry, hematology, coagulation, and complete urinalysis (fasted for at least 8 hours) results at screening and Day -1
Key exclusion criteria (29 listed)
- Has a history of or current clinically significant medical illness including (but not limited to) pulmonary, cardiovascular, coagulation disorders, lipid abnormalities, gastrointestinal, immunologic, endocrine, neurologic, psychiatric, or thromboembolic disease, metabolic disturbances, or any other current physical condition that the investigator considers should exclude the participant, or that could interfere with the interpretation of the study results.
- Has current or recent (within 6 months) history of gastrointestinal disease (except for appendectomy, inguinal/umbilical hernia), or any surgical or medical condition such as Crohn's disease or liver disease, that could potentially alter the absorption, metabolism, or excretion of the study drugs.
- Has any clinically significant medical condition, physical examination finding, ECG abnormality, or clinically significant abnormal value for clinical chemistry, hematology, coagulation, or urinalysis at Screening or at admission to the study center, as deemed appropriate by the investigator.
- Has any of the following (participant may rescreen once for failure to meet criteria at Screening):
- History or presence of malignancy within the past 5 years, except for adequately treated localized skin cancer (basal cell or squamous cell carcinoma), which is allowed.
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 |
|---|---|---|
| HA115Test Drug | Drug | Multiple Ascending Dose, Single Ascending Dose and Food effect |
| PlaceboPlacebo | Drug | Multiple Ascending Dose, Single Ascending Dose and Food effect |
Primary outcome
Adverse event (AE)
Time frame: 36 days
Percentage of subjects experiencing adverse event (AE).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Study Officials study director
Conjupro Biotherapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HA115 in people with Asthma, run by Conjupro Biotherapeutics, Inc. at 1 site in United States.
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 9 inclusion and 29 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: withdrawn, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Adverse event (AE) (time frame: 36 days). 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 8 Sep 2021.