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  • VY7523-102: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in Participants with Early Alzheimer's Disease

    Phase

    1/2

    Span

    117 weeks

    Sponsor

    Voyager Therapeutics

    Decatur, Georgia

    Recruiting

  • A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM

    This is a 28-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy, safety, and tolerability of four different once-weekly MET097 dosing regimens vs. placebo for body weight loss in adults (18-75 years of age) with obesity or overweight (body mass index [BMI] ≥27 to ≤50 kg/m2) and T2DM . After completing 28 weeks of study treatment, all participants will be followed for approximately 4 weeks after administration of the last dose of study treatment.

    Phase

    2

    Span

    68 weeks

    Sponsor

    Metsera

    Decatur, Georgia

    Recruiting

  • A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

    Phase

    3

    Span

    184 weeks

    Sponsor

    Otsuka Pharmaceutical Development & Commercialization, Inc.

    Decatur, Georgia

    Recruiting

  • Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders

    Phase

    1

    Span

    36 weeks

    Sponsor

    Bristol-Myers Squibb

    Decatur, Georgia

    Recruiting

  • A Phase 2b Study to Evaluate the Efficacy and Safety of Once-Monthly MET097 in Adults With Obesity or Overweight

    This is a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of multiple once monthly (QM) dose levels of MET097 after 12 once weekly (QW) doses, compared to placebo. The study will include adult participants with obesity or overweight. Participants will initially receive once weekly MET097 with or without titration or placebo for 12 weeks. Participants will then transition to a four-fold higher monthly dose for a total of 13 monthly doses. The primary endpoint is at Week 28, four weeks after the fourth monthly dose. All participants will be followed for ~5 half-lives after administration of the last dose for safety.

    Phase

    2

    Span

    83 weeks

    Sponsor

    Metsera

    Decatur, Georgia

    Recruiting

  • Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder

    Phase

    1

    Span

    116 weeks

    Sponsor

    Intra-Cellular Therapies, Inc.

    Decatur, Georgia

    Recruiting

  • Drug Screening System Method Comparison

    This study will compare positive and negative test results obtained from fingerprint sweat using the Intelligent Fingerprinting DSC-7 Drug Screening Cartridge versus opiates in sweat collected via the Fingerprint Collection Kit for Laboratory Analysis, within healthy males and non-pregnant females. The primary objective is to compare the sensitivity, specificity, and accuracy of the Intelligent Fingerprinting Drug Screening System to the validated confirmatory LC-MS/MS technique. The secondary objectives are to assess drug screening system usability and reproducibility. "Operators" comprise nine (9) adults: male and female subjects who operate the drug screening system. These subjects are not administered any drug. "Operators" represent end users who utilize the screening system in a laboratory setting. "Operators" will be provided the Intelligent Fingerprinting Drug Screening Guide, Confirmatory Laboratory Analysis Guide, and Quick Reference Guide, and be trained in system use. After receiving and reviewing all materials, the "operator" will complete a Training Exam to determine if he or she may proceed with testing. "Donors" comprise 135 healthy adults: male and non-pregnant female subjects who provide fingerprint sweat specimens. Subjects will be randomized into the blocks administered 0, 30, or 60mg of codeine sulfate in tablet form. "Donors" represent end users either applying for employment or working at an organization that conducts pre-employment and/or periodic workplace drug screening.

    Phase

    N/A

    Span

    19 weeks

    Sponsor

    Intelligent Bio Solutions Inc.

    Decatur, Georgia

    Recruiting

    Healthy Volunteers

  • A Phase 2 Randomized Double-Blind, Parallel, Adaptive-Design, Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR with NRCT-202XR Compared to NRCT-202XR Alone in Subjects with Attention-Deficit/Hyperactivity Disorder

    A multi-center, randomized, double-blind, parallel, adaptive-design clinical trial to evaluate the safety and efficacy of co-administration of NRCT-101SR and low dose NRCT- 202XR compared to low or high dose of NRCT-202XR and placebo NRCT-101SR over a 6-week period in approximately 60 pediatric subjects (13-17 years of age) with ADHD. Subjects' enrollment will be conducted in two stages. In stage 1, subjects are planned to be randomized to one of the following two arms (1:1 ratio): Arm 1: NRCT-101SR and low dose NRCT-202XR Arm 2: NRCT-101SR placebo and high dose NRCT-202XR In stage 2, a third study arm will be added (Arm 3 - NRCT-101SR placebo and low dose NRCT-202XR. The study population will include male and female subjects (sex assigned at birth) of all races/ethnicities with ADHD.

    Phase

    2

    Span

    40 weeks

    Sponsor

    Neurocentria, Inc.

    Decatur, Georgia

    Recruiting

  • Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder

    The study will be conducted in 3 periods: - Screening Period (up to 2 weeks) during which patient eligibility will be assessed and the washout of prohibited medications will occur; - Double-blind Treatment Period (6 weeks) during which a total of approximately 570 patients are planned to be randomized in a 1:1:1 ratio to receive one of the 3 treatments (ITI-1284 10 mg, ITI-1284 20 mg, or placebo); - Safety Follow-up Period (1 week) during which all patients will return for a safety follow-up visit approximately 1 week after the last dose of study drug.

    Phase

    2

    Span

    136 weeks

    Sponsor

    Intra-Cellular Therapies, Inc.

    Decatur, Georgia

    Recruiting

  • Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy

    Phase

    3

    Span

    139 weeks

    Sponsor

    Vertex Pharmaceuticals Incorporated

    Decatur, Georgia

    Recruiting

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