A Phase 1 Study to Assess the Safety of NLY01 in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Safety and Tolerability in Healthy Volunteers

In brief

This is a Phase 1, first-in-human study designed to assess the safety, tolerability, and pharmacokinetics of NLY01, a PEGylated form of exenatide, in healthy volunteers. NLY01 is being developed as a potential treatment for neurodegenerative disorders including Parkinson's disease. This study is intended to identify the appropriate dose-range for evaluation in Parkinson's disease patients.

Key facts

Study ID: NCT03672604
Run by: Neuraly, Inc.
People needed: 96
Starts: 2018-09-19
Expected to finish: 2019-07-30
Last updated by the study team: 2019-09-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Men or women, 18 to 65 years of age, inclusive.
BMI ≥ 18.5 and ≤ 32.0 kg/m2 at screening and check-in. BMI = weight (kg)/(height [m])2.
Women of child-bearing potential must agree to use a medically acceptable method of contraception from screening through 30 days after the final dose of study drug.
Non-childbearing potential.
Men who are sexually active and whose partners are women of child-bearing potential must agree to use condoms from screening through 90 days after administration of study drug, and their partners must be willing to use a medically acceptable method of contraception (a barrier method, intrauterine device, or hormonal contraception) from screening through 90 days after administration of the last dose of study drug.
Men must agree to not donate sperm from screening through 90 days after study drug administration.
Subjects must be able to communicate effectively with the study personnel.
Subjects must be healthy and without clinically significant abnormalities as assessed by review of medical and surgical history, physical examination, vital signs measurement, ECG, and laboratory evaluations conducted at screening and on Day -1 Check-in. A single repeat measurement/test may be performed to confirm vital signs, ECG, and clinical laboratory tests abnormalities (ie, to confirm that a subject is eligible).
Subjects must be nonsmokers, defined as having abstained from tobacco- or nicotine containing products (eg, cigarettes, chewing tobacco, snuff, nicotine patches, and electronic cigarettes) in the 6 months prior to screening.
Subjects must be informed of the nature and risks of the study and give written informed consent prior to screening.

You may not qualify if…

Positive pregnancy test or is lactating/breastfeeding.
History or presence of conditions which, in the judgment of the investigator, are known to interfere with the distribution, metabolism, or excretion of drugs.
History or presence of conditions that may place the subject at increased risk as determined by the investigator.
History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study.
History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of screening.
Use of prescription, OTC drugs (including herbal preparations) within 7 days or 5 half lives (if known), whichever is longer, prior to administration of the first dose of study drug.
Has received a vaccination within 14 days prior to administration of the first dose of study drug.
Has taken other investigational drugs or participated in any clinical study within 60 days or 5 half-lives (if known) of the investigational drug's PK, PD, or biological activity (if known), whichever is longer, prior to administration of the first dose of study drug in this study or is currently participating in another clinical study.
Prior exposure to exenatide (Byetta® or Bydureon®).
Significant blood loss (> 450 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to study randomization.
History of hypoglycemia.
History of gastroparesis.
History of pancreatitis.
Positive urine results for drugs of abuse, alcohol, or cotinine screen.
Positive screen for HIV-1 and HIV-2 antibodies, HBsAg, or HCV antibody.
Clinically significant cardiac changes demonstrated by ECG at screening or Day-1 including:
QTcF interval > 450 msec
PR interval ≤ 110 msec or > 240 msec
Evidence of second- or third-degree atrioventricular block
Pathological Q-waves (defined as Q-wave > 40 msec or depth greater than 0.5 mV)
Evidence of ventricular pre-excitation
Evidence of complete left BBB, incomplete left BBB, complete right BBB
Intraventricular conduction delay with QRS duration > 120 msec
Bradycardia (defined as sinus rate < 50 bpm) or tachycardia (defined as sinus rate > 100 bpm)
Has any of the following abnormal vital signs at screening or Day-1:

Where it is running

ICON Early Phase Services/CRU — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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