Phase I Study of XTL6001 Injection in Healthy and Obese Subjects

Recruiting Phase 1 Interventional Study
Weight Management in Adult Patients With Obesity or Overweight
Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Shanghai Xitaili Biomedicine Technology co., Ltd. · Industry
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About This Trial

This is a multicenter, randomized, double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) and multiple ascending dose (MAD) of XTL6001 injection in healthy and obese adult subjects. SAD study: Includes 5 dose cohorts, with 40 subjects planned for enrollment. MAD study Includes 2 dose cohorts, with 30 subjects planned for enrollment.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: Inclusion Criteria for Subjects in SAD part: 1. Age ≥ 18 and \< 65 years at screening. 2. Body mass index (BMI) ≥ 18.5 kg/m² and \< 28.0 kg/m² at screening. 3. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening. 4. Signed informed consent form prior to the t…
Contacts

Xiao Hua Hao, Ph.D. in Medicine

010-63926883

xiaohualuck@sina.com

CONTACT