A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers
NCT04551534 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2020-09-16
Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study conducted in three parts.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
DNL201
Oral dose(s)
- DRUG
-
Oral dose(s)
Sponsors & Collaborators
-
Denali Therapeutics Inc.
lead INDUSTRY
Principal Investigators
-
Danna Jennings, MD · Denali Therapeutics Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-06-01
- Primary Completion
- 2018-08-08
- Completion
- 2018-08-08
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A First-in-Human Study of KINE-101 in Healthy Volunteers
NCT07343323 ·Status: COMPLETED ·Phase: PHASE1
-
First in Human Study of NI-0701 in Healthy Volunteers
NCT01255501 ·Status: COMPLETED ·Phase: PHASE1
-
A First-in-Human Single and Multiple Ascending Dose Study of MT-201
NCT07219368 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants
NCT05483998 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42721458 in Healthy Male Participants
NCT01840501 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of HNC042 in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics.
NCT03740555 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Doses of GC021109 in Healthy Subjects
NCT02254369 ·Status: COMPLETED ·Phase: PHASE1
-
1a/1b Study of OPT101 First in Human Study Assessing Safety and Tolerability of 15-mer Peptide.
NCT04589403 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Single Doses of SBT115301 in Healthy Participants
NCT05388981 ·Status: COMPLETED ·Phase: PHASE1
-
First-in-human Study to Assess the Safety and Pharmacokinetics of LML134 in Healthy Volunteers
NCT02334449 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate ALN-4285 in Adult Healthy Volunteers
NCT07295717 ·Status: RECRUITING ·Phase: PHASE1
-
A Single Ascending Dose Study of CD101 IV in Healthy Subjects
NCT02516904 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate Safety, Tolerability, PK and PD of ALXN1007 in Healthy Subjects
NCT01454986 ·Status: COMPLETED ·Phase: PHASE1
-
Single Ascending Dose Study of WAL0921 in Healthy Subjects
NCT05891366 ·Status: COMPLETED ·Phase: PHASE1
-
MLN3126 Single Rising Dose Study
NCT02447458 ·Status: TERMINATED ·Phase: PHASE1
-
Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects
NCT01489345 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Healthy Volunteers
NCT02596399 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42847922 in Healthy Participants
NCT02230878 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics Study Assessing Ascending Single Oral JTK-853 Doses in Healthy Subjects
NCT01475981 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GEn1E-1124
NCT04728061 ·Status: COMPLETED ·Phase: PHASE1
-
First in Men Study of Single Oral Doses of ASP1941 in Healthy Subjects
NCT01288885 ·Status: COMPLETED ·Phase: PHASE1
-
A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374
NCT02245828 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Dose of GV101 in Healthy Subjects
NCT05068947 ·Status: COMPLETED ·Phase: PHASE1
-
An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects
NCT02551549 ·Status: COMPLETED ·Phase: PHASE1
-
A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects
NCT02125435 ·Status: COMPLETED ·Phase: PHASE1