A Phase 1 Study of PTX-35 in Healthy Volunteers

Status Withdrawn

Clinical Trial Summary

A Phase 1, Single Dose-Escalation and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous PTX-35 Adminsitration in Healthy Volunteers

Clinical Trial Description

This is a double blind, placebo controlled, Phase 1 study of PTX-35 administered via IV infusion to healthy male and female participants. This study will be conducted in 2 stages: - Stage 1 is a single ascending dose (SAD) escalation period in which 5 dose levels of PTX-35 will be evaluated. - Stage 2 is a multiple dose period in which the highest tolerated dose determined from Stage 1 will be tested in 2 different treatment regimens in 2 cohorts (i.e., 7- and 14- days dosing regimen). ;

Study Design

Related Conditions & MeSH terms

Healthy Volunteer

Clinical Trial Details

NCT number	NCT05116969
Study type	Interventional
Source	Heat Biologics
Contact
Status	Withdrawn
Phase	Phase 1
Start date	November 24, 2021
Completion date	November 29, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06326723` - Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects	Phase 1
Recruiting	`NCT00001367` - Diagnosis and History Study of Patients With Different Neurological Conditions
Completed	`NCT02699710` - Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects	Phase 1
Completed	`NCT02231892` - Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study	N/A
Not yet recruiting	`NCT06441916` - Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions	Phase 1
Completed	`NCT03771586` - A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects	Phase 1
Not yet recruiting	`NCT06337422` - Bioequivalence Study of Generic Celecoxib 200 mg Capsules	Phase 1
Completed	`NCT03302182` - Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects	Phase 1
Completed	`NCT05049343` - Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants	Phase 1
Recruiting	`NCT01629108` - Normal Values in Hearing and Balance Testing
Completed	`NCT02947854` - Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant	Phase 1
Completed	`NCT02534870` - Pharmacokinetics and Safety of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects	Phase 1
Completed	`NCT02224053` - Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers	Phase 1
Completed	`NCT01676584` - A Study of Single Dose RO6811135 in Healthy Volunteers	Phase 1
Completed	`NCT01684891` - A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers	Phase 1
Completed	`NCT01697436` - A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets	Phase 1
Completed	`NCT01711762` - A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers	Phase 1
Completed	`NCT01461967` - A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers	Phase 1
Completed	`NCT02547259` - Influence of Emotion in a Test Run Forgetfulness	N/A
Completed	`NCT01433575` - A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers	Phase 1