Skip to content

A Phase 1, Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease

A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00626184
Enrollment
28
Registered
2008-02-29
Start date
2008-02-29
Completion date
2008-07-31
Last updated
2009-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Keywords

Celiac Disease

Brief summary

To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac Disease

Detailed description

A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease

Interventions

DRUG4 dose levels of ALV003

4 dose levels of ALV003 vs placebo

Sponsors

Alvine Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

INCLUSION * Health Status 1. Healthy volunteers must be in good health 2. Celiac Disease must be well controlled and in good health * Either male or non-lactating, non-pregnant females who are postmenopausal, sterile or using at least two acceptable and highly effective birth control methods. * Body Mass Index (BMI) of \< 30 kg/m2, EXCLUSION * A positive urine test for alcohol or illegal drugs at screening. * The subject has received an experimental drug within 30 days of the present study. * History of substance abuse, within the last 5 years * Clinically significant abnormal lab values, as determined by the PI * Alcohol consumption of \> 2 standard drinks equivalents per day12. Positive pregnancy test within 7 days prior to study drug administration. * history of any medically significant condition considered by the PI to adversely affect participation in the trial

Design outcomes

Primary

MeasureTime frame
safety and tolerabilityThroughout

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026