A single-center, randomized, double-blind, placebo-controlled, parallel-group studie investigating the safety, tolerability and pharmacokinetics of single- and multiple-ascending subcutaneous doses of TA-46 in healthy volunteers

Completed

• Conditions: Achondroplasia; dwarfism; 10083624

• Registration Number: NL-OMON48911
• Lead Sponsor: Therachon SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 102

Inclusion Criteria

- healthy male or female subjects
- female volunteers sterilized or post-memopausal
- 21-55 yrs, inclusive
- BMI: 18.0-28.0 kg/m2, inclusive
- non-smoking or light smokers (smoking not allowed in clinic)

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of
participation in another drug study within 90 days before the start of this
study or being a blood donor within 60 days from the start of the study. In
case of donating more than 1.5 liters of blood in the 10 months prior the start
of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the safety and tolerability of single and multiple ascending doses<br /><br>of TA-46 administered to healthy male and female subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the pharmacokinetics (PK) of TA-46 following single and multiple<br /><br>ascending doses<br /><br>To compare the safety, tolerability, and pharmacokinetics of single doses of 2<br /><br>formulations of TA-46.</p><br>