Trials / Completed
CompletedNCT06037577
Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects
A Double-Blind, Randomized, Placebo-Controlled, Phase I Study To Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Escalating Subcutaneous Doses of CM-101 in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- ChemomAb Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
CM-101 is developed as treatment for medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc). In this current study, the IP is tested in healthy male volunteers.
Detailed description
A single-center, randomized double-blind, placebo-controlled, single-dose study Healthy volunteers were screened for up to 28 days prior to drug administration. The study included one dose group of 8 subjects. A single 5 mg/kg CM-101 dose was subcutaneously administered. The study was comprised of a screening period, a treatment day, a follow-up (FU) period of 42 days and an end of study (EOS) FU visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CM-101 | Anti-human CCL24 monoclonal antibody (CM-101) |
| DRUG | Placebo | Placebo Comparator |
Timeline
- Start date
- 2019-03-05
- Primary completion
- 2019-05-05
- Completion
- 2019-05-05
- First posted
- 2023-09-14
- Last updated
- 2023-09-14
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT06037577. Inclusion in this directory is not an endorsement.