Phase 1
N=24
A Phase 1 Study of EXT608 in Healthy Adults
Safety Issues
Bottom Line
View on ClinicalTrials.gov: NCT05408663 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Characterize the Safety and Tolerability of EXT608 — 2; 2; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- EXT608 (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Extend Biosciences Inc.
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Characterize the Safety and Tolerability of EXT608 |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Characterize the Safety and Tolerability of EXT608 |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Characterize the Safety and Tolerability of EXT608 |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Single Dose Pharmacokinetics (PK) - Area Under the Curve (AUC) |
NA; NA; NA; 358.3; 1613; 4903 | — |
| SECONDARY Single Dose PK - Cmax |
NA; NA; NA; 489.3; 1156; 4967 | — |
| SECONDARY Single Dose PK - Tmax |
NA; NA; NA; 3.3; 5.3; 2.7 | — |
Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose safety and tolerability study of EXT608 in healthy subjects. There will be up to 6 sequential dose escalation cohorts of 4 participants. In each cohort 3 participants will receive EXT608 and 1 participant will receive placebo.
Eligibility Criteria
Inclusion Criteria
- Male or female between 18 and 55 years of age.
- Body mass index between 18.5 and 32 kilogram per square meter (kg/m2), inclusive, with a body weight greater than or equal to (>=) 45 kg.
- In general good medical health with no clinically significant or relevant abnormalities,
- A clinical safety laboratory parameter of hemoglobin greater than (>) 11.7 gram per deciliter (g/dl) (females) or 13.1 g/dl (males) and less than ( 1.5 the upper limit of normal (ULN)
- Increased baseline risk for osteosarcoma
Data sourced from ClinicalTrials.gov (NCT05408663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.