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Safety and Tolerability of TWP-201 in Healthy Female Subjects

NCT04878705 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-07-19

No results posted yet for this study

Summary

This study is a randomized, double-blind, placebo-controlled, single dose, escalation, phase I clinical trial to evaluate the safety and tolerability of recombinant human follicle stimulating hormone Fc fusion protein injection (TWP-201) in healthy female subjects. The objective of the trial is to evaluate the safety and tolerability of TWP-201 in healthy female subjects.

Conditions

Interventions

DRUG

TWP-201

a single subcutaneous injection

DRUG

placebo

a single subcutaneous injection

Sponsors & Collaborators

  • Shandong TheraWisdom Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shengbin Ren · Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2022-10-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT04878705 on ClinicalTrials.gov