Clinical trials: Phase 1b
Pain
Omnitram Pharmacokinetic and Analgesic Study Following CY2D6 Inhibition With Paroxetine In Healthy Volunteers
This study evaluates the analgesic effect of Omnitram and tramadol during concurrent administration of paroxetine. Paroxetine administration is expected to diminish the analgesic effect of tramadol, but not Omnitram.
- Trial name
- NCT03312777
- Testing
- Omnitram, Tramadol
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Syntrix Biosystems, Inc.
HIV Infections
Evaluating the Safety and Immunogenicity of the IHV01 Protein Vaccine Primed and Co-Administered With HIV DNA CON-S Env Vaccine in Healthy, HIV-1-Uninfected Adults
The purpose of this study is to evaluate the safety and immunogenicity of the IHV01 protein vaccine primed and co-administered with HIV DNA CON-S env vaccine in healthy, HIV-1-uninfected adults.
- Trial name
- NCT03505060
- Testing
- DNA CON-S env, IHV01
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Intrinsic Aging of Skin
Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis
This is an early phase study comparing two fixed dose of the study compound ELAPR and a Restylane® Vital Light (control), by multiple intradermal injections to a 3cm x 3cm area of the upper arm dermis.
- Trial name
- NCT01466413
- Testing
- Tropoelastin
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Elastagen Pty Ltd
Healthy
Study to Determine the Safety, Tolerability and Pharmacokinetics Following Multiple Doses of LX4211 in Healthy Subjects
The primary objective of this study is to evaluate the safety and tolerability of multiple oral doses of LX4211 400 mg and LX4211 800 mg (administered once daily for 10 consecutive days) in healthy subjects.
- Trial name
- NCT01916850
- Testing
- LX4211 400 mg, LX4211 800 mg
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
Malaria
Safety, Tolerability, Pharmacokinetics, and Mosquitocidal Activity of Lotilaner in Healthy Participants in Mali.
This is a Phase 1b, single-cente, randomized, double-blind, placebo-controlled proof-of-concept study evaluating the safety, tolerability, pharmacokinetics and mosquitocidal activity of single oral doses of lotilaner in healthy…
- Trial name
- NCT07758985
- Testing
- Cohort 1 low dose lotilaner with a high-fat meal, Cohort 2 high dose lotilaner in fasted state, Cohort 3 high dose lotilaner with a high-fat meal
- Where
- Mali
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Covid19
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults
This is a phase 1b, open-label study in adult healthy participants. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.
- Trial name
- NCT04710303
- Testing
- hAd5-S-Fusion+N-ETSD vaccine
- Where
- South Africa
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- ImmunityBio, Inc.
Hepatitis B
A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)
Normal healthy volunteer (NHV) participants will enroll sequentially into a total of 6 escalating dose levels (6 subjects per dose level), randomized to receive a single dose of ARC-521 Injection or placebo.
- Trial name
- NCT02797522
- Testing
- ARC-521 Injection, antihistamine, acetaminophen
- Where
- New Zealand
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
TB Multi-drug Resistant
Dose Escalation Study of SQ109 in Healthy Adult Volunteers
The purposes of this study are to determine: how safe it is to take SQ109 (an experimental tuberculosis treatment) once a day by mouth for up to 2 weeks in 2 different dosages; how well the body accepts it; how SQ109 enters and…
- Trial name
- NCT00866190
- Testing
- SQ109
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Evaluating the Safety and Immune Response to Five Different Combinations of HIV Vaccines in Healthy, HIV-Uninfected Adults
This study will evaluate the safety and immune response to five different combinations of three HIV vaccines in healthy, HIV-uninfected adults.
- Trial name
- NCT01964937
- Testing
- DNA-HIV-PT123, NYVAC-HIV-PT1, NYVAC-HIV-PT4
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chronic Hepatitis B
Study of HBV Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B
The goal of this clinical study is to learn more about GS-2829 and GS-6779 in healthy participants and participants with CHB.
- Trial name
- NCT05770895
- Testing
- GS-2829, GS-6779
- Where
- 9 sites in New Zealand, Taiwan
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
HIV Infections
Evaluating the Safety and Immune Response to Different Combinations of the DNA-HIV-PT123 and AIDSVAX® B/E Vaccines in Healthy, HIV-Uninfected Adults
This study will evaluate the safety, tolerability, and immune response to different combinations of two experimental HIV vaccines-the DNA-HIV-PT123 vaccine and the AIDSVAX® B/E vaccine-in healthy adults who are not infected with…
- Trial name
- NCT02207920
- Testing
- AIDSVAX B/E Vaccine, DNA-HIV-PT123 Vaccine
- Where
- 7 sites in United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Respiratory Syncytial Virus Infections
Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children
This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose.
- Trial name
- NCT04444284
- Testing
- Investigational RSV vaccine MV-012-968 (Dosage 1), Investigational RSV vaccine MV-012-968 (Dosage 2), Investigational RSV vaccine MV-012-968 (Dosage 3)
- Where
- 3 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Meissa Vaccines, Inc.
Pediculosis Capitis (Head Lice)
A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age
This is an open label, single center, single dose PK study of NatrOVA Creme Rinse (1%), an investigational treatment for head lice and nits, in normal, healthy infants.
- Trial name
- NCT00410709
- Testing
- NatrOVA Creme Rinse (1%)
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- ParaPRO LLC
Healthy Volunteers, Chronic Kidney Disease
A Study of RBT-9 in Healthy Volunteers and Volunteers With Stage 3/4 Chronic Kidney Disease
This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-9 in healthy volunteers and in subjects with Stage 3/4 CKD.
- Trial name
- NCT04072861
- Testing
- RBT-9
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Renibus Therapeutics, Inc.
Chronic Spontaneous Urticaria
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of Tacabrutideg (BGB-16673) in Adults With Chronic Spontaneous Urticaria and in Healthy Participants
This is a Phase 1b study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of multiple-ascending doses of tacabrutideg in adults with chronic spontaneous urticaria (CSU) and in healthy participants.
- Trial name
- NCT07005713
- Testing
- Tacabrutideg
- Where
- 9 sites in China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- BeOne Medicines
Chronic Anal Fissure
E-CEL UVEC Treatment for Anal Fissures
This clinical trial is being conducted by investigators who are colorectal surgeons. Eligible study participants will receive the experimental treatment E-CEL UVEC cells by direct injection into the anal fissure.
- Trial name
- NCT06456073
- Testing
- E-CEL UVEC cells (AB-207)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
Exocrine Pancreatic Insufficiency
Oral CDX-7108 in Healthy Adults and EPI Subjects
Phase 1a/1b single and multiple ascending dose study of oral CDX-7108 in healthy adult subjects and a single dose proof-of-concept study of oral CDX-7108 in subjects with exocrine pancreatic insufficiency.
- Trial name
- NCT05082051
- Testing
- Part A, Part B, Part C
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Allergic Rhinitis, Allergic Rhinitis Due to Grass Pollen
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis
This is a Prospective, Controlled, Double Blinded, Single Center, Randomized, 3 Arm, Parallel Assignment, Phase 1b/2a Study to assess the safety, tolerability, and preliminary efficacy of B244 delivered as an intranasal spray in…
- Conditions
- Allergic Rhinitis, Allergic Rhinitis Due to Grass Pollen, Healthy Volunteers
- Trial name
- NCT03290248
- Testing
- B244 suspension, Vehicle
- Where
- 2 sites in United States, Canada
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- AOBiome LLC
Idiopathic Pulmonary Fibrosis (IPF), Idiopathic Pulmonary Fibrosis
PET Study of PIPE-791 in Healthy Volunteers and Volunteers With PrMS and IPF
This is a study of PIPE-791, an investigational study drug to treat progressive multiple sclerosis (MS) and idiopathic pulmonary fibrosis (IPF).
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF), Idiopathic Pulmonary Fibrosis, Multiple Sclerosis, Multiple Sclerosis, MS
- Trial name
- NCT06683612
- Testing
- PIPE-791
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Contineum Therapeutics
Domestic Violence, Substance Abuse
The Men's Domestic Abuse Check-Up Engages Adult Men Concerned About Their Abusive Behavior and Alcohol or Drug Use
This research is a stage 1b developmental trial evaluating an intervention called "The Men's Domestic Abuse Check-Up" with adult men abusing their intimate partners and also struggling with alcohol or drug use.
- Trial name
- MDACU (NCT01621334)
- Testing
- Motivational Enhancement Therapy, Educational information
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University of Washington