Clinical trials: First in Man Study to Evaluate Initial Safety
First-In-Human Study to Evaluate Safety of a New Drug Intended for Treatment of Acute Ischemic Stroke
A Phase 1 Study to Evaluate Safety and Tolerability of NoNO-42 in Healthy Adults
The purpose of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics of a single ascending intravenous dose of NoNO-42 administered to healthy adults.
- Trial name
- NCT05636306
- Testing
- NoNO-42
- Where
- Canada
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- NoNO Inc.
Viral; Infection, Coxsackie(Virus)
PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers
Phase 1, first-in-human, randomized, double-blind, placebo-controlled, multiple-dose-escalation study to evaluate the safety, tolerability and immunogenicity of PRV-101, a coxsackie virus B vaccine, in healthy volunteers.
- Trial name
- PROVENT (NCT04690426)
- Testing
- PRV-101
- Where
- Finland
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Provention Bio, Inc.
Ebola Virus Infection
Safety, Tolerability and Pharmacokinetic First in Human (FIH) Study for Intravenous (IV) TKM-100802
Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single ascending dose (SAD) study followed by a multiple-dose cohort in healthy male and female subjects.
- Trial name
- NCT02041715
- Testing
- TKM-100802 for Injection
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Arbutus Biopharma Corporation
Advanced Malignant Solid Tumor, Solid Tumor Cancer
A First in Human Study of PLT012 in Participants With Solid Tumor Cancers
The goal of this clinical trial is to learn about what doses of PLT012 are safe to use in adults with advanced cancers in solid tumors. It will also learn about how effective different doses of PLT012 are in treating cancer.
- Trial name
- NCT07337525
- Testing
- PLT012
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- Pilatus Biosciences Inc
Healthy
A Study in Healthy Subjects to Assess the Safety, Tolerability and Pharmacokinetics of HTL0022562
Phase 1, randomised, double-blind, first in human, two part, single centre, placebo controlled, single and multiple ascending dose trial in healthy adult subjects to evaluate the safety, tolerability and pharmacokinetics of…
- Trial name
- NCT04941989
- Testing
- HTL0022562
- Where
- United Kingdom
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Nxera Pharma UK Limited
Pharmacokinetics
The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males
To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by intravenous infusion (iv) and subcutaneous (sc) injection.
- Trial name
- NCT01276119
- Testing
- CDP6038
- Where
- Germany
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Atrial Arrhythmias
The Field PULSE Study
This is a pre-market, first-in-human, pilot, interventional, clinical investigation that aims to evaluate safety and feasibility of the FieldForce™ Ablation system in patients with atrial fibrillation who are indicated for an AF…
- Trial name
- NCT06452589
- Testing
- FieldForce Ablation System
- Where
- Czechia
- Volunteers
- 35 people
- Sponsor
- Field Medical
Phenylketonuria, Healthy
Safety and Tolerability of SYNB1618 in Healthy Adult Volunteers and Adult Subjects With Phenylketonuria
This Phase 1/2a, first-in-human, oral single and multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB1618 in healthy volunteers (HV) and subjects diagnosed with phenylketonuria (PKU)…
- Trial name
- PKU (NCT03516487)
- Testing
- SYNB1618
- Where
- 4 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Synlogic
Solid Tumor
ALG.APV-527 First-in-human Study
A first-in-human, multicenter, open-label, dose escalation and dose expansion phase 1 study in patients with advanced solid tumors to evaluate the safety of intravenously administered ALG.APV-527 (Short title: ALG.APV-527…
- Trial name
- NCT05934539
- Testing
- ALG.APV-527
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Aptevo Therapeutics
Solid Tumor, Advanced Solid Tumor
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
The goal of the Monotherapy Dose Escalation phase (Part 1) of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for…
- Conditions
- Solid Tumor, Advanced Solid Tumor, Solid Tumor, Adult, Metastatic Tumor
- Trial name
- NCT06586957
- Testing
- NKT3964, Paclitaxel, Doxorubicin
- Where
- 20 sites in United States, South Korea
- Volunteers
- 238 people
- Sponsor
- NiKang Therapeutics, Inc.
Advanced Solid Tumors
Phase I Study of SM2275 Injection in Patients With Advanced Solid Tumors
This is a first-in-human, multicenter, open-label Phase Ia/Ib study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of SM2275 in patients with…
- Trial name
- NCT07750132
- Testing
- SM2275
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Beijing StarMab Biomed Technology Ltd
Healthy
A First-in-Human SAD/MAD Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ENC1018 in Healthy Adult Subjects
This is a Phase 1, FIH, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and PK characteristics of ENC1018 after single and multiple oral dose administration in healthy adult subjects.
- Trial name
- NCT06224400
- Testing
- ENC1018 for SAD, ENC1018 for MAD
- Where
- Australia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- EnnovaBio Australia Pharmaceuticals Pty Ltd
Hepatitis B, Chronic
Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection
A First-Time-In-Human study on GSK's therapeutic vaccines to evaluate the reactogenicity, safety, immunogenicity and efficacy on reduction of serum HBV surface antigen in HBV suppressed participants under nucleo(s)tide treatment.
- Trial name
- NCT03866187
- Testing
- ChAd155-hIi-HBV low dose formulation, ChAd155-hIi-HBV high dose formulation, HBc-HBs/AS01B-4 low dose formulation
- Where
- 43 sites in Belgium, France and 7 more
- Volunteers
- 236 people
- Sponsor
- GlaxoSmithKline
Advanced CEACAM6-expressing Solid Tumors
Study of BAY1834942 in Patients With Solid Tumors
This is an open-label, Phase 1, first-in-human, dose escalation and expansion study designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and tumor response profile of the…
- Trial name
- NCT03596372
- Testing
- BAY1834942
- Where
- 4 sites in United States, Canada and 1 more
- Volunteers
- 30 people
- Sponsor
- Bayer
Healthy
First in Human Study of ANXV (Recombinant Human Annexin A5) in Healthy Volunteers
This is an adaptive, randomised, double-blind, single-centre, placebo-controlled phase I, First in Human study designed to evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous dosing of ANXV…
- Trial name
- NCT04850339
- Testing
- ANXV
- Where
- Netherlands
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Annexin Pharmaceuticals AB
Muscular Dystrophies
First Time in Human (FTIH) Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of GSK3439171A in Healthy Subjects and to Assess Food Effect
The FTIH study with GSK3439171A will evaluate the safety of GSK3439171A in healthy subjects in order to avoid confounding factors due to the disease or concomitant drugs in patients.
- Trial name
- NCT03627494
- Testing
- GSK3439171A
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Solid Tumors
First-in-human Study With the Antibody-drug Conjugate SYD985 to Evaluate Safety and Efficacy in Cancer Patients
The purpose of this study is to evaluate the safety of a new medicinal drug SYD985 at different dose levels in patients with cancer, to understand how SYD985 is handled by the body and to evaluate the effect of SYD985 on the…
- Trial name
- NCT02277717
- Testing
- SYD985 (trastuzumab vc-seco-DUBA)
- Where
- 15 sites in Belgium, Netherlands and 2 more
- Volunteers
- 185 people
- Sponsor
- Byondis B.V.
Healthy
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Subjects
The purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 (Intravenous dose) and Part 3 (Subcutaneous dose) and potential for reversibility of JNJ-64179375 induced Pharmacodynamic effects on…
- Trial name
- NCT02949206
- Testing
- JNJ-64179375, 4 Factor Prothrombin Complex Concentrate (PCC)
- Where
- Belgium
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Oral Civamide Safety, Tolerability First in Human Study
Safety and pharmacokinetic first-time-in-human study of orally administered civamide in healthy subjects.
- Trial name
- NCT00802217
- Testing
- Civamide
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Winston Laboratories
GI Cancers
First-in-human Study of 7MW4911 in GI Cancer
This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.
- Trial name
- NCT07216560
- Testing
- 7MW4911
- Where
- 6 sites in United States
- Volunteers
- 200 people
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.