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

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 - TA-46 SAD and MAD dose study to investigate safety and PK

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48911

Enrollment

102

Registered

2018-01-09

Start date

2018-01-19

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achondroplasia dwarfism

Interventions

Part A: Each group consists of 8 volunteers with 6 subjects receiving TA-46 as a subcutaneous injection / infusion and the 2 subjects receiving a single dose placebo. Part B: Each group consists of

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of single and multiple ascending doses of TA-46 administered to healthy male and female subjects.	—

Secondary

Measure	Time frame
To evaluate the pharmacokinetics (PK) of TA-46 following single and multiple ascending doses To compare the safety, tolerability, and pharmacokinetics of single doses of 2 formulations of TA-46.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)