NCT07118085

A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMC-003 for Injection in Healthy Postmenopausal Women

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Academic / Other
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

this study is a randomized, double-blind, placebo-controlled, single and multiple dose escalation Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IMC-003 for injection in healthy postmenopausal women.

Conditions

• Healthy Postmenopausal Women

Interventions

Type	Name	Description
DRUG	experimental Arm IMC-003	Part 1: Single Dose Dose Escalation (SAD): single administration, with the test drug or placebo administered respectively. Part 2: Multiple Dose Dose Escalation (MAD): Administer for 5 consecutive times (unless the subject cannot tolerate, withdraw prematurely, or is lost to follow-up, etc.), with the test drug or placebo administered respectively.
DRUG	The placebo Arm: The placebo of IMC-003	Part 1(SAD) subject will receive IMC-003 once ; Part 2 (MAD) subject will receive the placebo of IMC-003 for 5 times, with an interval of 21 days between each administration.

Timeline

• Start date: 2025-08-18
• Primary completion: 2027-05-20
• Completion: 2027-08-20
• First posted: 2025-08-12
• Last updated: 2025-12-15

Locations

1 site across 1 country: China