Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With Asthma

AbbVie

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Placebo; Drug: ABT-308

Study type: Interventional

Funder types: Industry

Identifiers

NCT00986037

M10-378

Details and patient eligibility

About

The primary purpose of this study is to determine the safety, tolerability and pharmacokinetics of ABT-308 in healthy volunteers and patients with mild to moderate controlled asthma.

Enrollment: 47 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers:

  1. A condition of good health based upon the results of medical history, physical examination, vital signs, laboratory profile and ECG.
  2. BMI 18 to 29, inclusive.

• Mild asthma patients:

  1. Diagnosis of well-controlled, mild to moderate asthma by GINA guidelines for > or = to 6 months
  2. A condition of good health (than mild to moderate asthma) based upon the results of medical history, physical examination, vital signs laboratory profile and EDG.
  3. BMI 18 to 34, inclusive.

Exclusion criteria

1. Asthma exacerbation within 8 weeks of Study Day 1.
2. Clinically significant allergic reaction to any drug, biologic, food, or vaccine.
3. History of allergic reaction or significant sensitivity to constituents of study drug.
4. Receipt of any investigational product within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
5. Subject is a smoker or has a history of smoking within the 6-month period preceding study drug administration.
6. Current enrollment in another clinical study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

---

47 participants in 3 patient groups

IV ABT-308 in asthmatics

Experimental group

Description:

ABT-308 single escalating doses in mild to moderate asthmatics

Treatment:

Drug: Placebo

Drug: ABT-308

Drug: Placebo

Drug: ABT-308

SC ABT-308 in asthmatics

Experimental group

Description:

ABT-308 multiple SQ doses in mild to moderate asthmatics

Treatment:

Drug: Placebo

Drug: ABT-308

Drug: Placebo

Drug: ABT-308

IV ABT-308 in healthy volunteers

Experimental group

Description:

ABT-308 single escalating IV doses in healthy volunteers

Treatment:

Drug: Placebo

Drug: ABT-308

Drug: Placebo

Drug: ABT-308