NCT04085523 - A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 24, 2020

Primary Completion Date

September 27, 2022

Study Completion Date

October 1, 2024

Conditions

Achondroplasia

Interventions

DRUG

TransCon CNP

TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.

DRUG

Placebo for TransCon CNP

Weekly subcutaneously injection of placebo.

Trial Locations (15)

1023

Ascendis Pharma Investigational Site, Auckland

2100

Ascendis Pharma Investigational Site, Copenhagen

3052

Ascendis Pharma Investigational Site, Parkville

4020

Ascendis Pharma Investigational Site, Linz

13353

Ascendis Pharma Investigational Site, Berlin

14203

Ascendis Pharma Investigational Site, Buffalo

53705

Ascendis Pharma Investigational Site, Madison

55102

Ascendis Pharma Investigational Site, Saint Paul

65212

Ascendis Pharma Investigational Site, Columbia

72211

Ascendis Pharma Investigational Site, Little Rock

77030

Ascendis Pharma Investigational Site, Houston

80045

Ascendis Pharma Investigational Site, Aurora

98105

Ascendis Pharma Investigational Site, Seattle

D01 YC76

Ascendis Pharma Investigational Site, Dublin

3000-602

Ascendis Pharma Investigational Site, Coimbra