NL-OMON48177
Completed
Not Applicable
A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of LAM-001 in Patients with Lymphangioleiomyomatosis - LAM-001-LAM-CLN03
AI Therapeutics0 sites6 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AI Therapeutics
- Enrollment
- 6
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The patient is independently capable of providing informed consent
- •and provides signed informed consent, witnessed by clinic staff, before
- •any study\-related assessments or procedures are performed.
- •2\. The patient is female and from 18 to 70 years of age, inclusive, with a
- •body mass index from 18\.0 to 32\.0 kg/m2, inclusive, at the time of
- •screening (Visit 1\)
- •a. Patients cannot be pregnant or lactating/breast feeding and must be
- •surgically sterile, postmenopausal (no menses for the previous 12
- •months), or practicing a highly effective method of birth control as
- •described in this protocol. Acceptable methods of birth control are:
Exclusion Criteria
- •1\. The patient has a pre\-bronchodilator FEV1 of \*60% of predicted
- •during the screening or baseline visits.
- •2\. The patient has used mTOR inhibitors (e.g., rapamycin, everolimus)
- •within 90 days before Visit 1\.
- •3\. The patient is considered likely to need oral rapamycin or another
- •mTOR inhibitor within 6 months following Visit 1, in the opinion of the
- •investigator.
- •4\. The patient has had a pneumothorax within the 2 months before Visit
- •5\. The patient is a smoker. Patients will be defined as ex smokers and
- •eligible for participation in the study if they have not consumed tobacco
Outcomes
Primary Outcomes
Not specified
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