Healthy Volunteer StudyEarly Phase 1NCT05881993
Study of CBP-4888 in Healthy, Non-Pregnant Female Subjects
A Early Phase 1 study testing CBP-4888 in people with Healthy Volunteer Study, run by Comanche Biopharma at 1 site in United States.
Trial summary
This is a Phase I, first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of ascending doses of CBP-4888. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- CBP-4888
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2023to 22 May 2024
- Phase
- Early 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy non-pregnant female subjects
- Body mass index (BMI) ≥ 18.5 and ≤ 35.0 kg/m2
- Medically healthy, defined as having no clinically significant abnormal screening results including clinical laboratory evaluations, medical history, vital signs, ECG, and physical examination as deemed by the Investigator.
Who cannot join
- Screening blood pressure < 100/60 mmHg or > 140/90 mmHg
- Screening heart rate that is < 40 bpm or > 99 bpm
- Clinically significant ECG abnormality at screening
- Used prescription medication within 14 days prior to dosing
- Used over the counter (OTC) medications (including herbal products, nutritional supplements, dietary supplements, and/or vitamins) within 7 days prior to dosing
- Donated blood or had significant blood loss within 56 days prior to dosing
Trial locations and contacts
1 site in 1 country.
United States1 site
Comanche Biopharma Clinical Research Site #1
San Antonio, Texas, 78217
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CBP-4888 in Healthy, Non-Pregnant Female Subjects
This is a Phase I, first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of ascending doses of CBP-4888.
Read the detailed description
This study will involve female subjects meeting all inclusion criteria and no exclusion criteria. Cohorts of CBP-4888 are planned to be investigated in a sequential dose-escalation manner. Each cohort of subjects will be randomized to CBP-4888 to placebo and administered a single subcutaneous dose.
- Conditions
- Healthy Volunteer Study
- Being tested
- CBP-4888, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBP-4888Drug
siRNA therapeutic
PlaceboOther
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| CBP-4888 | Experimental | CBP-4888 administered once as a subcutaneous dose. Receives: Drug: CBP-4888 |
| Placebo | Placebo comparator | Normal Saline administered once as a subcutaneous dose. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of participants with treatment-related adverse events
Measured: 30 days
Pain at Site of Injection
Assessment of Pain on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
Measured: 30 days
Tenderness at Site of Injection
Assessment of Tenderness on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
Measured: 30 Days
Erythema at Site of Injection
Assessment of Erythema on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
Measured: 30 days
Swelling at Site of Injection
Assessment of Swelling on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
Measured: 30 Days
Secondary outcomes (3)
Cmax of CBP-4888
Peak Plasma Concentration
Measured: 30 days
AUC of CBP-4888
Area Under the Plasma Concentration Versus Time Curve
Measured: 30 days
Tmax of CBP-4888
Time to maximum plasma concentration
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start22 May 2023
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comanche Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allison August, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881993
- Sponsor's protocol ID
- CBP-4888-100
- Status last verified
- Sep 2025
- First submitted
- 9 May 2023
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CBP-4888 in Healthy, Non-Pregnant Female Subjects
- ClinicalTrials.gov ID
- NCT05881993
- Acronym / sponsor ID
- CBP-4888-100
- Conditions
- Healthy Volunteer Study
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Comanche BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 22 May 2023 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 31 May 2023 (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 Phase I, first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of ascending doses of CBP-4888.
Detailed description
This study will involve female subjects meeting all inclusion criteria and no exclusion criteria. Cohorts of CBP-4888 are planned to be investigated in a sequential dose-escalation manner. Each cohort of subjects will be randomized to CBP-4888 to placebo and administered a single subcutaneous dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBP-4888 | Experimental | Drug: CBP-4888CBP-4888 administered once as a subcutaneous dose. |
| Placebo | Placebo comparator | Other: PlaceboNormal Saline administered once as a subcutaneous dose. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy non-pregnant female subjects
- Body mass index (BMI) ≥ 18.5 and ≤ 35.0 kg/m2
- Medically healthy, defined as having no clinically significant abnormal screening results including clinical laboratory evaluations, medical history, vital signs, ECG, and physical examination as deemed by the Investigator.
Key exclusion criteria (6 listed)
- Screening blood pressure < 100/60 mmHg or > 140/90 mmHg
- Screening heart rate that is < 40 bpm or > 99 bpm
- Clinically significant ECG abnormality at screening
- Used prescription medication within 14 days prior to dosing
- Used over the counter (OTC) medications (including herbal products, nutritional supplements, dietary supplements, and/or vitamins) within 7 days prior to dosing
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-4888siRNA therapeutic | Drug | CBP-4888 |
| PlaceboNormal Saline | Other | Placebo |
Primary outcome
Adverse Events
Time frame: 30 days
Number of participants with treatment-related adverse events
Pain at Site of Injection
Time frame: 30 days
Assessment of Pain on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
Tenderness at Site of Injection
Time frame: 30 Days
Assessment of Tenderness on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
Erythema at Site of Injection
Time frame: 30 days
Assessment of Erythema on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
Swelling at Site of Injection
Time frame: 30 Days
Assessment of Swelling on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
3 secondary outcomes
Cmax of CBP-4888
Time frame: 30 days
AUC of CBP-4888
Time frame: 30 days
Tmax of CBP-4888
Time frame: 30 days
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 26 Sep 2025.
- 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.
Allison August, MD study director
Chief Medical Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CBP-4888 in people with Healthy Volunteer Study, run by Comanche Biopharma 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 3 inclusion and 6 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 26 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Adverse Events (time frame: 30 days). The study lists 5 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 26 Sep 2025.