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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

NCT07118085 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-12-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2027-05-20
Completion
2027-08-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07118085 on ClinicalTrials.gov