Clinical trials: First in Man Study to Evaluate Initial Safety
Colorectal Cancer, Colorectal Cancer (CRC)
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS/MSI-L Colorectal Cancer
This study will investigate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CBI-1214 in participants with advanced or metastatic Microsatellite Stable (MSS)/Microsatellite Instability Low (MSI-L) Colorectal…
- Conditions
- Colorectal Cancer, Colorectal Cancer (CRC), Colorectal (Colon or Rectal) Cancer, CRC
- Trial name
- NCT07321106
- Testing
- CBI-1214
- Where
- 10 sites in United States
- Volunteers
- 80 people
- Sponsor
- Cartography Biosciences
Healthy
First-in-human Study in Healthy Subjects
This initial Phase I study will evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending doses of CORT118335, the effect of concomitant administration with food on exposure to CORT118335, and…
- Trial name
- NCT03315338
- Testing
- CORT118335, 25 mg, Prednisone Oral Tablet, Glucose
- Where
- United Kingdom
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Corcept Therapeutics
Influenza, Human
Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults
The goal of this clinical trial is to evaluate the safety and immune responses of three different dose levels a self-amplifying RNA pandemic influenza vaccine (ARCT-2304) in adults.
- Trial name
- NCT06602531
- Testing
- ARCT-2304, Control vaccine younger adults, Control vaccine older adults
- Where
- 4 sites in United States
- Volunteers
- 212 people, healthy volunteers welcome
- Sponsor
- Arcturus Therapeutics, Inc.
Pharmacokinetics in Healthy Adults
Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects
The study will evaluate safety, tolerability and PK profile of 5-MeO-DMT in healthy subjects
- Trial name
- NCT05032833
- Testing
- 5-MeO-DMT
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Beckley Psytech Limited
Alopecia Areata
A Study to Evaluate the Safety of MAX-40070 in Healthy Subjects
This is a First-in-Human phase I study to evaluate the safety, tolerability and pharmacokinetic characteristics of MAX-40070 in Healthy SubjectThe study will be comprised of 2 parts; Part A and Part B.
- Trial name
- NCT05196711
- Testing
- MAX-40070
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Maxinovel Pty., Ltd.
HIV
A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults
Background: HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs.
- Trial name
- VRC 611 (NCT04408963)
- Testing
- VRC-HIVMAB0102-00-AB
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Advanced Solid Tumors
A Phase I First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WGI-0301 in Patients With Advanced Solid Tumors
The purpose of this study is to learn about the effects of a study medicine, WGI-0301 to find the best dose for treating solid tumors, and to see how safe and tolerable the study drug is for patients with solid tumors.
- Trial name
- NCT05267899
- Testing
- WGI-0301
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Zhejiang Haichang Biotech Co., Ltd.
Advanced Solid Tumors
A Phase I Study of JS108 in Patients With Advanced Solid Tumors
This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, PK profile and efficacy of JS108 for patients with advanced solid tumors.
- Trial name
- NCT04601285
- Testing
- JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection)
- Where
- 3 sites in China
- Volunteers
- 25 people
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
Cardiovascular Diseases
A First-in-human Study of YN001 in Healthy Volunteers
This will be a single center, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study in healthy adult subjects.
- Trial name
- NCT05635084
- Testing
- YN001
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Beijing Inno Medicine Co., Ltd.
Healthy
Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy Volunteers
The main purpose of this study is to assess the safety and tolerability of AZD5847 after receiving oral doses on a single day (Part A) or after receiving a single oral dose in two periods (Part B).
- Trial name
- NCT01037725
- Testing
- AZD5847
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Advanced Malignant Tumors
First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors
This study is designed as an open-label, multi-center Phase 1 clinical study in participants with advanced malignant tumors to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of JMT108…
- Trial name
- NCT06877650
- Testing
- JMT108, Pembrolizumab, Ivonescimab
- Where
- China
- Volunteers
- 436 people
- Sponsor
- Shanghai JMT-Bio Inc.
Depressive Disorder and Anxiety Disorders
First Study in Humans With GSK424887
This is the first study in Humans with GSK424887 to evaluate what effects, good or bad, the drug has on human health (safety and tolerability) and the amount of drug which gets into the bloodstream and is eliminated from the body…
- Trial name
- NCT01059591
- Testing
- GSK424887, PET
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Advanced Solid Tumor
A Phase 1 Study of HS130 in Combination With Viagenpumatucel-L (HS110) in Patients With Solid Tumors
This is a phase 1 open-label, single center, dose escalation study to determine a safe and effective maximum tolerated dose of HS-130 in combination with viagenpumatucel-L (HS-110) for adult subjects with advanced solid tumors…
- Trial name
- NCT04116710
- Testing
- HS-110 (viagenpumatucel-L), HS-130
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Heat Biologics
Atopic Healthy Subjects, Adult Subjects with Mild Allergic Diseases
A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases
The purpose of this study is to evaluate the safety, tolerability, PK, and PD following subcutaneous injections of YH35324 in atopic healthy subjects or adult subjects with mild allergic diseases.
- Trial name
- NCT05061524
- Testing
- YH35324, Omalizumab
- Where
- 4 sites in South Korea
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Primary Mitochondrial Diseases
A First in Human Study to Evaluate the Safety of Infusion of MNV-BM-PLC (Autologous CD34+ Cells Enriched With Placenta Derived Allogeneic Mitochondria) in Patients With Primary Mitochondrial Diseases Associated With Mitochondrial DNA Mutation or Deletion
The study objectives are to evaluate the safety of a single intravenous (IV) infusion of autologous CD34+ cells enriched with placenta-derived allogeneic mitochondria in participant with primary mitochondrial disease associated…
- Trial name
- NCT04548843
- Testing
- Bone Marrow mobilization, Apheresis, MNV-BM-PLC infusion
- Where
- Israel
- Sponsor
- Minovia Therapeutics Ltd.
Influenza, Human
Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults
This is a safety and Immunogenicity first-in-human dose-ranging study of self-amplifying RNA Seasonal Influenza Vaccine (ARCT-2138) in adults.
- Trial name
- NCT06125691
- Testing
- ARCT-2138, Licensed Quadrivalent Vaccine for younger adults, Licensed Quadrivalent Vaccine for older adults
- Where
- 2 sites in Australia
- Volunteers
- 139 people, healthy volunteers welcome
- Sponsor
- Arcturus Therapeutics, Inc.
Inflammatory Disease, Autoimmune Diseases
A Dose Escalating Study of HC002 in Healthy Adult Volunteers
This is a first-in-human (FIH) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending oral doses of HC002 in healthy adult participants.
- Trial name
- NCT06670274
- Testing
- HC002 SAD, HC002 MAD
- Where
- Australia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Holoclara Aus Pty Ltd
Pneumococcal Vaccine
A Study to Evaluate Tolerability, Safety and Immunogenicity of MVX01 Pneumococcal Vaccine
The objectives of this first-in-human study is to evaluate the tolerability, safety, and immunogenicity of MVX01, a pneumococcal vaccine candidate, at four dose levels.
- Trial name
- NCT06337643
- Testing
- MVX01
- Where
- 2 sites in United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Matrivax Research and Development Corporation
Heart Failure
V-LAP™ Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heaRt Failure
The purpose of the trial is to evaluate the safety, usability and performance of the V-LAP™ System in adult subjects with New York Heart Association (NYHA) Class III Heart Failure.
- Trial name
- VECTOR-HF (NCT03775161)
- Testing
- V-LAP™ System
- Where
- 2 sites in Germany, Italy
- Volunteers
- 45 people
- Sponsor
- Vectorious Medical Technologies Ltd.
Chronic Hepatitits C
First in Human Study of AL-704; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C
This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human, 3-part study in which the safety, tolerability, and pharmacokinetics of orally administered AL-704 will be assessed in healthy adult subjects and in…
- Trial name
- NCT02510248
- Testing
- AL-704
- Where
- 3 sites in France, Georgia and 1 more
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma Inc.